OFFICE FOR HARMONIZATION IN THE INTERNAL MARKET (TRADE MARKS AND DESIGNS)

Portfolio & Quality Management Service

Quality Management System Manual

Office for Harmonization in the Internal Market
Version 9.0 01/08/2012

Project Status Approved by Owner Author Contributors

ISO 9001 Project APPROVED NS NS CDN ADC JH QG JR BG Head of Portfolio and Quality Management Service Niloofar Simon Claire Duranton Andrea Di Carlo John Hemington Quality Officers in Quality Group Juan Ramon Rubio Beatrice Garavelli

Revision History
Version 1.0 2.0 3.0 4.0 4.1 Date 25/04/2007 27/03/2009 06/04/2009 09/09/2009 20/10/2009 Author ADC, CDN, RS CDN CDN CDN JH, VOR Description Version for publication Approved version Version sent for revision and translation Final Version Updated in line with OHIM June 2009 reorganisation (sections 2.3 and 3); with responsibilities of Process Owner, Quality Officer, Process Expert and Quality Manager roles added (section Appendix B); ISO 9001 certification scope clarified (section 2.5); text added to describe OHIMs approach to record control and identification and traceability (5.6), control of nonconforming product, corrective action and preventive action (section 4.4.2); EMAS reference added (section 2.5). Includes revised sections 3.5, 3.10 and 4.5 from DIPP to reflect the OHIM June 2009 reorganisation and changes to responsibilities. 4.2 25/10/2009 JH Updated in line with review comments of Quality Officers and the Internal Auditor, plus additional text on record retention (5.6), and latest Process Model (4.4). Inserted comments from Directors and Approved by Management Committee of the Office on 09/11/2009. Updated in line with new organisation chart. Updated, reviewed and approved. Ready for publication on OAMI-Online. Updated in line with new organisation chart. Ready for publication on OAMI-Online. Revision after re-organisation and simplification of contents Further edits. Distributed to Quality Officers for review. Inclusion of review comments from Quality Manager, PQMS Formatting Approved version Updated Quality Policy, Mission, scope of certification, Presidents role, Strategic Plan and Balanced Scorecard, continual improvement, and general tidying up. Reviewed before submission to Head of Service, PQMS Included feedback from PQMS Head of Service, AH and JH. Prepared approved version

5.0 5.1 5.2 6.0 6.1 7.0 7.1 7.2 7.3 7.4 8.0 8.1

10/11/2009 28/02/2011 10/03/2011 11/03/2011 29/06/2011 30/06/2011 09/11/2011 17/11/2011 24/11/2011 25/11/2011 25/11/2011 14/06/2012

CDN CDN CDN CDN BG BG BG JH CDN BG CDN NS, JH

8.2 9.0

15/06/2012 01/08/2012

CDN CDN

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TABLE OF CONTENTSVERSION 9.0 01/08/2012 .................................................................................................................... 1 REVISION HISTORY .............................................................................................................................. 2 THE OHIM QUALITY POLICY ................................................................................................................ 4 1. INTRODUCTION .............................................................................................................................. 5 1.1 1.2 1.3 2. STATUS AND ORGANISATION OF THE OFFICE ................................................................................. 5 STRATEGIC GOALS OF THE OFFICE .............................................................................................. 5 SCOPE OF THE QUALITY MANAGEMENT SYSTEM OF THE OFFICE (QMS) ........................................ 5

QMS ROLES AND RESPONSIBILITIES ........................................................................................ 7 2.1 2.2 2.3 2.4 2.5 2.6 2.7 PRESIDENT ................................................................................................................................. 7 MANAGEMENT AND ADVISORY COMMITTEE ................................................................................... 7 DIRECTORS, HEADS OF HORIZONTAL SERVICES AND PROCESS OWNERS ....................................... 7 QUALITY OFFICERS AND PROCESS EXPERTS ................................................................................ 7 QUALITY OFFICERS GROUP ......................................................................................................... 8 INTERNAL AUDITOR AND INTERNAL AUDIT ..................................................................................... 8 QUALITY MANAGER ..................................................................................................................... 8

3.

QMS AT WORK ............................................................................................................................... 9 3.1 USERS NEEDS AND EXPECTATIONS .............................................................................................. 9 3.1.1 User Satisfaction Survey ................................................................................................... 9 3.1.2 Users complaints .............................................................................................................. 9 3.2 STRATEGIC PLAN AND BALANCED SCORECARD (BSC) ................................................................ 10 3.3 W ORK PROGRAMME .................................................................................................................. 11 3.4 SERVICE CHARTER .................................................................................................................... 11 3.5 PROCESSES AND KEY PERFORMANCE INDICATORS (KPIS) .......................................................... 11 3.5.1 Continual improvement .................................................................................................... 12 3.5.2 Process Mapping ............................................................................................................. 13 3.5.3 Decision-making in Industrial Property proceedings ....................................................... 14 3.6 MANAGEMENT OF PERFORMANCE .............................................................................................. 14

4.

QMS MAINTENANCE.................................................................................................................... 16 4.1 4.2 4.3 4.4 4.5 DOCUMENTATION ...................................................................................................................... 16 AUDITS ..................................................................................................................................... 16 SYSTEM REVIEW ....................................................................................................................... 17 AWARENESS, TRANSPARENCY AND SHARING OF INFORMATION .................................................... 17 RECORDS ................................................................................................................................. 17

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The OHIM Quality Policy

The main role and mission of OHIM is the fast, efficient and reliable delivery of Intellectual Property rights, while taking into consideration the need to promote further harmonization and convergence of practices within the European Union and with external partners, and to increase quality, timeliness and accessibility to the trade mark and design system. In order to fulfil its role in the period from 2011-2015, a strategic planning process was launched in October 2010 to provide an honest assessment of OHIM, to think expansively about where it might improve and where the Office could leverage its outstanding assets to ensure the greatest impact in convergence of practices for the benefit of IP users. The process was designed to be broad and inclusive, ensuring that all possible input is taken into account to build a strategy supported by all stakeholders and interested parties. As a result, a Strategic Plan was created, stating the Goals of the Office, setting Lines of Action and proposing Key Initiatives to be followed in order to achieve the Strategic Goals. While all the Key Initiatives of the Strategic Plan have as their ultimate objective to enhance the quality delivered by the Office to all its stakeholders, in particular the initiatives related to Line of Action 5: Improvement and Broadening of Quality (Holistic Quality) focus more closely on improving specific aspects of the users experience when interacting with OHIM. In terms of quality and improvement, OHIM will especially focus its attention on the following quality objectives: Optimising process efficiency Empowering users by making OHIMs decision making processes transparent Aligning first instance practices with Boards of Appeal and European Court practices Integrate users into OHIM practices Quality objectives support objective two of the Strategic Plan aiming at improving timeliness, predictability, consistency and additional dimensions of quality as perceived by users. Quality objectives and achievements will be reviewed within the strategic management cycle in 2013. The QMS will be integrated as part of OHIMs strategic management planning and will be linked to the Office Scorecard published in the SP. The OHIM Quality Management System (QMS) as part of the strategic management planning will be further developed and enhanced to support quality and facilitate continual improvement while providing a source of knowledge to OHIM staff. OHIM is committed to continually improving the effectiveness of the QMS within the framework of the Strategic Plan implementation. For this, each key initiative in the Strategic Plan is covered by a programme and/or project to achieve OHIMs vision. OHIM ensures to follow regulatory, statutory and customer requirements. Certification to ISO 9001 has been attained for all RCD-related activities. OHIM has now committed to extend that QMS certification to the whole Office by 2015; this is through Strategic Plan Key Initiative 26.

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1. Introduction
1.1 Status and organisation of the Office The Office is a public establishment that enjoys legal, administrative and financial autonomy. The Office was created under European Community law and is a European Community body with its own legal personality. Its activities are subject to Community law. The General Court and the Court of Justice of the European Communities are responsible for overseeing the legality of the Office's decisions. The Office is responsible for balancing its budget with its revenue, which is derived mainly from the fees for the application, registration and renewal of trade marks and designs. The latest organisation chart is available on the OHIM official website: http://oami.europa.eu/ows/rw/pages/OHIM/institutional/organisationalChart.en.do

1.2 Strategic Goals of the Office To achieve our vision, we are focusing on the following strategic goals :
1

Ref:
1 2 3

Goal
Build a Strong, Vibrant and Creative Organisation Increase Quality and Optimise Timeliness of Operations Promote Convergence of Practices

The Office strives to meet the customers needs and expectations and to make effective and efficient use of resources. Goals 2 and 3 have been defined to this end. The Quality Management System contributes to achieving all three Goals.

1.3 Scope of the Quality Management System of the Office (QMS) The Quality Management System serves the staff of the Office in applying its Quality Policy and in pursuing the consistent achievement of its Strategic Goals. The QMS applies to all activities and to everyone at the Office. The Office shall establish, document, implement and maintain the QMS and continually improve its effectiveness. The QMS comprises the three elements of people, processes and systems. The effectiveness of the QMS depends on having all three elements in place and aligned. The QMS is concerned with the sharing of best practice as well as the spreading and use of this knowledge. It aims at making available at one entry point all the relevant knowledge necessary to implement the processes. It supports collaboration across the OHIM and with the OHIMs service providers. The QMS defines the way that the OHIM currently works and provides the means for managing the Offices evolution. The initial focus of the QMS was on the core services relating to trade marks and designs that the Office provides to its Users (certification for designs achieved in 2009, trade marks will be included in 2012). The QMS will be extended in phases until it is able to support all the activities of the Office: support processes will be included in 2013-2014 and management processes in 2014-2015. The QMS has been designed to meet the requirements of ISO (International Organization for Standardization) 9001, and the part of the system which relates to Designs processing was certified successfully in 2009. Specifically, the scope for certification is as follows:

The strategic goals are stated in the OHIM Strategic Plan 2011-2015

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All activities that relate to the processing of Registered Community Design (RCD) applications and International Registrations of Design, including the updating and maintenance of the Registered Community Designs Register and information about RCD holders and their representatives. In 2012 the scope of certification changes to: All activities that relate to the processing of Community Trade Mark (CTM) applications, Registered Community Design (RCD) applications, international registrations of Trade Marks and Designs, appeals to the Boards of Appeal, and the updating and maintenance of the CTM Register, RCD Register and information about CTM and RCD owners and their representatives. Matters relating to information security are addressed by the OHIM Information Security Management System which has achieved certification to ISO 27001.Matters relating to environmental management are addressed by the OHIM Environmental Management System which has achieved certification to EMAS requirements. OHIM is implementing an Occupational Health and Safety System to comply with OHSAS 18001.

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2. QMS roles and responsibilities

2.1 President The President is the sponsor of the OHIM Quality Policy (see Message from the President of the Office in paragraph 1 above). He is committed to the Quality Policy and its quality objectives. He ensures that the Quality Management System is established and maintained in order to achieve these objectives. 2.2 Management and Advisory Committee The Management and Advisory Committee (MAC) of the Office has overall responsibility for the Quality Management System. It establishes its scope, priorities, roles and responsibilities. The Committee defines the organisations priorities for the achievement of Quality Goals and supervises the functioning of the Quality Management System to ensure that performance is aligned to the Goals. The MAC runs an annual review of the QMS as part of the Strategic Planning Cycle to ensure that it is operating effectively. 2.3 Directors, Heads of Horizontal Services and Process Owners Directors and Heads of Horizontal Services are responsible for the processes in their area. Each Director or Head of Horizontal Service may delegate process ownership responsibilities to others by confirming Process Owners for processes owned by the department or horizontal service. The Process Owner responsibilities are: Managing the process so that it meets user requirements and delivers business value. Ensuring that the right mix of communications and training are provided to the people who carry out the process. Establishing and using suitable performance measures. Ensuring that the process and any supporting documentation is updated and remains aligned to supporting IT systems. Ensuring that the process is aligned to and remains aligned to OHIM policy and all governing regulations. Ensuring that resources are at the right level for efficient and effective process performance. Ensuring that the Quality Officer(s) and Process Experts have objectives related to the role and are appraised accordingly.

2.4 Quality Officers and Process Experts Each Director or Head of Horizontal Service may delegate process support responsibilities to others by confirming one or more Quality Officers and Process Experts for processes owned by the department. Quality Officers implement, maintain and improve the Quality Management System. They provide leadership and guidance on quality issues in their respective department or horizontal service, and liaise with the Quality Manager to keep her informed. Quality Officers work closely with the Process Experts, who are individuals with expertise in relation to specific processes. The respective responsibilities are defined as follows: Quality Officer - Supporting the Process Owner in working with and supporting the process so that it meets user requirements and delivers business value. - Coordinating ISO readiness preparations and QMS maintenance for the area, including mapping any new processes that are required. - Delivering suitable communications and training to the people who carry out the process in coordination with Process Experts. - Setting up and adjusting performance measures using the performance indicators and ensuring that actual measures and performance indicators remain aligned. Reporting on process performance to the Process Owner. Quality Manual_EN.doc Page 7 of 17

Maintaining accurate and useful referencing from the process card, to supporting documentation and IT systems. - Maintaining regular contact with the Process Expert to ensure a two-way flow of information about the process and to ensure process maintenance/update. - Acting as a channel for feedback from the people using the process, including handling improvement ideas (in case of Business changes, representing the department and bringing a horizontal perspective). Process Expert - Providing expertise in developing and maintaining up-to-date processes, including in relation to supporting documentation and IT systems. This includes mapping new processes as required. - Serving as a point of contact for technical questions about the process and providing the answers to those who raise questions. - Maintaining an awareness of how people are using the process, so that communication and training needs can be identified and satisfied. - Liaising with the Quality Officer on process questions, issues and improvement ideas. 2.5 Quality Officers Group The Quality Officers Group consists of Quality Officers and representatives of the Portfolio and Quality Management Service. The Group meets regularly to review QMS plans, ISO implementation activities, communications and training products. It participates in and supports benchmarking initiatives. It contributes to the development, implementation and maintenance of the QMS. 2.6 Internal Auditor and Internal Audit The Internal Auditor is responsible for Internal Audit (IA) activities within the Office. The authority of the IA is derived from the President of the Office and is governed by the Institute of Internal Auditors standards and practice notes. The purpose of the IA is to assist management and provide independent, objective assurance and consulting services designed to add value and improve the organisations operations. It helps the organisation accomplish its objectives by bringing a systematic, disciplined approach so it can evaluate and improve the effectiveness of risk management, control, and governance processes. Some of the Quality Officers and Process Experts have been trained on ISO Internal Audit and they perform one or more internal audits per year together with Internal Audit team. 2.7 Quality Manager The Quality Manager is responsible for: Ensuring alignment of QMS with OHIM Strategic Plan. Maintaining the architectural integrity of the QMS. Ensuring that the processes link together correctly. 2 Ensuring compliance with standards, including ISO 9001 . Ensuring that the QMS is effective. Ensuring that processes needed for the quality management system are established, implemented and maintained, Reporting to top management on the performance of the Quality Management System Ensuring promotion of awareness of customer requirements throughout the organisation

The Management Representative is the Head of Service of Portfolio and Quality Management Service and is responsible for promoting systematic continual improvement to deliver organisational benefits within Strategic Plan framework.

This includes the responsibility to ensure that all documents of external origin that are necessary for the planning and operation of the QMS are subject to controlled distribution.

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3. QMS at work

3.1 Users needs and expectations The Office aims to fulfil Users needs and expectations while meeting legal requirements and making efficient use of resources. The Office gathers User opinions concerning the services it offers through different channels, for example, through users groups for trade marks, focus groups for designs, the E-business User Group, meetings with users associations and liaison meetings. Another important tool to get user feedback for the Office is through its Information Centre where all information requests are processed. Through these channels, Users advise the Office on how to develop new tools. Furthermore, to make sure that User feedback is integrated in how the Office works, the Office has set up systematic processes for surveying User needs and dealing with complaints. 3.1.1 User Satisfaction Survey The User Satisfaction Survey is generally conducted once a year. The objective of the Survey is to identify areas of improvement and to enable the Office to set appropriate priorities to enhance its services and to measure overall satisfaction. In summary, the aim is to create a virtuous circle in which User needs are used to set improvement goals. Achievement against goals is monitored through performance indicators and communicated to Users. This then leads to a fresh User input, thus creating a cycle in which the Office continually improves in the direction that its Users demand. A User 3 Satisfaction report to summarise the results of the Survey is published on the OHIMs website . 3.1.2 Users complaints Users have the right to complain about any aspect of the activities of the Office. Lodging a complaint must be simple and easy. Complaints must receive suitable answers in a timely manner. The Complaints Unit ensures the effective handling of complaints. The Unit maintains a register of complaints to ensure that they are treated and closed to the satisfaction of the User in a reasonable timescale. The analysis of and reporting on complaints provides a key feedback to OHIM for improvement.
3

OHIM website = http://oami.europa.eu/ and User satisfaction 2010 is published on

http://ec.europa.eu/internal_market/indprop/tm/index_en.htm

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3.2 Strategic Plan and Balanced Scorecard (BSC) OHIM has developed a Strategic Plan for 2011 to 2015. The two pillars of this strategy are to develop OHIM's own organisational excellence, building on the successes of the last 15 years, and to foster international cooperation with national IP offices and the Benelux Office for Intellectual Property (BOIP) to develop, over time, a comprehensive European Trade Mark and Design Network in which all have a key part to play.

OHIM will pursue three strategic goals sustained by the two pillars mentioned above. In terms of operational excellence, the first goal is to build a vibrant, creative organisation not only for its own sake but in order to pursue the second goal of continuing to increase quality and optimise the timeliness of OHIM's operations. Achievement of excellence and quality are considered as necessary conditions for OHIM to be able to achieve the third goal which is to promote convergence of practices towards the creation of a European Trade Mark and Design Network. A number of Lines of Action align with the two pillars, which in turn, support, to different degrees, the three strategic goals. The Lines of Action are: - HR Reform and Cultural Renewal - Simplification and Modernisation of Information Systems - Expansion and Optimisation of the Working Environment - Establishment of the IP Academy and Knowledge Repository - Improvement and Broadening of Quality - and Development of the European Network. Quality Manual_EN.doc Page 10 of 17

These Lines of Action are further broken down into a series of 33 Key Initiatives that collectively will serve the organisation as a roadmap towards 2015. Each initiative is associated with one or more detailed deliverables to track progress and achievement of results. OHIM will use a Balanced Scorecard (BSC) to monitor the implementation of the Strategic Plan. From the Key Initiatives a set of 20 strategic objectives was formulated. The BSC has been designed by defining indicators and milestones for all the objectives of the Plan. It provides a standardised way to track the strategy implementation, sets the Offices level of performance per year, enables integrated reporting and facilitates the decision making process at a strategic level. At an operational level the KPIs cascaded from the BSC are linked to the defined QMS processes. 3.3 Work Programme The Work Programme is the document that transforms organisational goals into operational terms. It defines: - the initiatives/projects to be carried out for each line of activity - the measurable objectives - the service standards to which the Office wants to commit vis--vis Users - the performance targets that core processes must meet to enable compliance with service standards. A one-year Work Programme and three-year budget estimate are prepared. An annual revision of the Programme is undertaken to adapt it to changing circumstances.
4

3.4 Service Charter The Service Charter lists the Service Standards defined in the Work Programme. Service Standards set the desired levels of service Users would expect the Office to meet. The standards cover both process performance (standards of time, accessibility, etc.) and the quality of 5 decisions made during Industrial Property proceedings . The Charter is drafted by the Economics & Statistics Service, approved by the Management and Advisory Committee and published on the OHIMs intranet and website. Performance against the listed standards is evaluated at the end of each quarter and reported publicly online. The Charter is revised annually. A report on the performance of the Office, when compared to the Service Standards, is issued at the end of each year and published on OHIMs website (Annual Report). 3.5 Processes and Key Performance Indicators (KPIs) The OHIMs processes are based on a plan designed to ensure clarity, aptness and consistency and to avoid duplication. The OHIMs processes are organised into eight main process areas: A - Manage Stakeholder Relationships B - Maintain Business Planning C - Manage Changes in Programmes, Projects and Services D - Deliver Core Business Services E - Deliver Core Business Support Services
4

A Balanced Scorecard translates an organisation's strategy into a comprehensive set of performance measures that provides the framework for a strategic measurement and management system. This is the appropriate tool to monitor the execution of the Strategic Plan and to enable the identification of the strategic key drivers. As part of the Cooperation Fund (CF) Programme, OHIM is collaborating with several National IP Offices in an initiative to harmonise and enhance the experience of users with all EU IP Offices by selecting common quality standards and making them available through a Common Service Charter. This is project CF 1.2.5.
5

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F Manage and Deliver Project G - Monitor and Report H Deliver General Support Services

The OHIM processes are published on the QMS pages of the intranet. The decision to map a process and then to use the result to manage the activity and the performance, is taken on the basis of one or more of the following criteria: Is of business priority, e.g. part of core business Has to be mapped for knowledge retention purposes Has risks associated with it which need to be managed Requires cross-departmental collaboration Needs shared understanding to ensure quality of the output.

3.5.1 Continual improvement Process Owners and Quality Officers are committed to continually searching for ways to improve the processes they are responsible for in order to meet Users requirements in a more efficient and consistent manner. Improvements must include being faster, more process-centric, more serviceoriented, more agile, more reliable, and more cost-effective. This involves simplifying processes, eliminating bureaucracy, striving for transparency and enhancing expertise. It also means becoming a true electronic or e-office where geography and time should be irrelevant when doing business with the OHIM. All staff at OHIM is authorised to suggest improvements and changes to processes by either contacting their Quality Officers or by emailing to QMS suggestions (QMS@oami.europa.eu). Staff improvement ideas and suggestions are registered and systematically dealt with. Quality Officers are responsible for the handling and implementation of improvements. OHIM is putting in place a common and transparent way of managing and tracking innovation ideas through its project management database. As part of the effort to improve quality and consistency throughout all the Office's operations, OHIM has introduced a new initiative to break down the silos between services and departments through "Knowledge Circles", which will bring colleagues from different areas together to discuss improvements. Quality Manual_EN.doc Page 12 of 17

The creation of Knowledge Circles is a useful method allowing staff from all areas to work together from the early stages of development of the Office's practice on trade marks and designs. The idea is to cultivate collective solutions rather than have proposals put forward by just one department. This approach will help cascade knowledge throughout the office and the Boards of Appeal will be able to participate as observers without jeopardising their institutional role. There are eight Knowledge Circles on specific IP issues: Proceedings: Examination proceedings and formalities (incl. Seniorities); opposition proceedings; cancellation proceedings; mediation. Goods & Services (G&S) issues: Classification; limitations; comparison of G&S. Absolute grounds (AG) for refusal: AG in examination and AG in invalidity; revocation (misleading, generic); geographical indications. Relative grounds (RG) for refusal: RG in opposition and RG in invalidity; revocation (use). Designs: Examination and invalidity; proceedings; audit on designs. Register and other issues: Transfers; licenses; inspections; certifications; renewals; recordals; Owners & Representatives (including representation before OHIM); Madrid; fees; legal advice on e-business. Enforcement: legal support to the observatory; fraud. International law: This circle gives legal support to the institutional and international services on topics such as the Associated Board/Budget Committee (AB/BC), bilateral agreements and other agreements.

In addition to covering IP matters there are two specific Knowledge Circles covering staff and financial matters. Collaboration across OHIM is being promoted in a variety of ways, including through the use of objectives and through specific liaison arrangements between various services. 3.5.2 Process Mapping Process cards are used for defining and documenting processes. The process cards are used as a management tool. In particular, each process card references and links to all relevant supporting material, including templates, sections of Manual, sections of guidelines, forms, checklists, etc. so that staff have the full picture for carrying out the activity each process card references each IT system that supports the activity staff who carry out roles in the process are informed about the process card, trained as necessary, and informed of changes process performance is measured and managed the effectiveness of quality controls and checks is measured and managed process improvement is encouraged.

Quality Officers prepare and update process cards in collaboration with the Quality Manager. Whenever processes are implemented for the first time or the process cards are updated, staff who perform the processes are notified through communications and/or training as appropriate. Whenever projects deliver changes to business processes, the scope of the project includes the new or changed process card(s) as well as any supporting IT tools. Process cards describe what corrective action the examiner or other member of staff should take when an error or deficiency is detected at a specific point in the process. If an error relating to premature or erroneous publication of an RCD is detected, this is handled using a specific process card. In other situations, if a member of staff detects an error or deficiency in a customer application or case file or in a product or service from one of OHIMs support departments, the individual will inform his or her Quality Officer. The Quality Officer is responsible for ensuring that such reports are noted, are analysed, that appropriate action is identified, and then carried out to resolve the issue, and that Quality Manual_EN.doc Page 13 of 17

records are maintained for subsequent review and audit. If an error or deficiency is detected in the QMS, this will be reported by clicking on a QMS suggestions button on any QMS page on the intranet. The same mechanism is used to handle suggestions or questions from staff members. Wherever relevant, process cards provide for the analysis of errors or deficiencies, the identification of root causes, and the identification and execution of preventive and corrective actions to prevent recurrence, including the raising and submitting of improvement ideas to make possible changes to IT systems, processes and organisation. Wherever relevant, process cards provide for a similar approach for eliminating potential nonconformities by identifying preventive actions. Whenever ad-hoc preventive or corrective action is needed, the individual who carries out the analysis is responsible for the identification of root causes, and the identification and execution of preventive and corrective actions to prevent recurrence, including the raising and submitting of improvement ideas to make possible changes to IT systems, processes and organisation. The effectiveness of the preventive and corrective actions taken has to be reviewed by the individual who has carried out the analysis. Quality Officers maintain a log of preventive and corrective actions for their areas. In addition to the quality controls that are described in most process cards, there are additional checks that are carried out for CTMs and others for RCDs. 3.5.3 Decision-making in Industrial Property proceedings Decision-makers in Industrial Property proceedings are provided with comprehensive, up-to-date guidance in the form of the Manual on Current CTM Practice and the Guidelines (for both Trade Marks and Designs). The Office has, for Trade Marks, a tool for electronic workflow (Euromarc++) and an electronic repository of files (AdminDocs). It is becoming an electronic office with increasing support tools for decision-making. Further tools for Trade Marks include the template generator, examiner desktop, Euroace classification search and tools to develop the building of the Opposition file. The guidance documents are published on the OHIMs website. Where changes in Trade Mark case-law, or other events, give rise to an immediate change of practice, this is reflected in a change to the Manual on Current CTM Practice, so that Examiners and external parties are informed about how the legal practice of the Office has changed on a specific matter. If the change of practice concerns a matter of potential controversy, a period of external consultation is opened to gather User opinion. Changes to the Manual are from time to time brought together as an update to the Guidelines (Trade Marks). Where changes to Designs case-law, or other events, require a change of practice, this is reflected in a change to the Guidelines (for Designs). The intention is to make sure Examiners take clear and consistent decisions and Users are aware of the guidance given to examiners so that they can reasonably predict the outcome of a decision on their application. 3.6 Management of Performance OHIM operates Quality Checks of examiner decisions in order to monitor and report on the quality of the decision-making. The aim is to reduce the possibility of making errors by providing more tools to help examiners (i.e. database on the similarity of goods and services, knowledge management tools, instructions to be followed by examiners, etc.). OHIM uses a range of reports to support the management of performance: The OHIM Dashboard is the platform for publishing the outcome of the Offices most important statistical indicators, in a graphical manner. It is updated on a weekly basis. A monthly report is published on INSITE (look for M.O.R.E.) on performance against the Service Standards and other measures. Performance against the Service Standards is also reported on a quarterly basis to the OHIM website (see section 3.4 above). Page 14 of 17

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An Annual Report is prepared at the end of each year and published on the OHIM website.

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4. QMS maintenance
4.1 Documentation The Quality Management System documentation comprises this Quality Manual and all the material that defines and supports the processes, as represented in the following diagram. The Office strives to make the processes - and all the related documentation - available in one single place which users can access easily (the complete list of processes including ownership, planning and list of people involved is available in a tool named QMS Process Index). OHIM documents are subject to the OHIM Document Control Policy. supported by the AdminDocs tool. Document management is

4.2 Audits Internal audits are carried out to verify whether actual working practice complies with the planned arrangements including the processes that govern the activity. Audits also help to identify necessary Quality Manual_EN.doc Page 16 of 17

improvements and to determine if processes are effective and efficient and if responsibilities have been correctly assigned. The subject and frequency of the audits depends on the number, importance and complexity of the activities to be audited and takes account of: Top management priorities Business risks The results of previous audits Significant changes to the organisation of the Office, Departments or to processes Significant changes to statutory or customer requirements The results of complaints or other customer feedback

The audits determine whether the Quality Management System is being effectively implemented and maintained and whether the requirements of ISO 9001 are being satisfied. The Office is subject to audit by the European Court of Auditors twice a year, by the certification body in relation to ISO 9001 and ISO 27001 once a year, and by the certification body in relation to EMAS (ISO 14001) once a year. In addition, the Office invites external audits of specific subjects of interest from time to time. 4.3 System Review The Quality Officers Group continually evaluates the effectiveness of the Quality Management System and makes proposals for improvement. The Portfolio and Quality Management Service reports to the Management and Advisory Committee on the performance of the system and any need for improvement within the framework of the Strategic Planning Cycle. 4.4 Awareness, Transparency and Sharing of Information Each member of staff, as well as Users and other stakeholders, must be made aware of the functioning and aim of the Quality Management System and its processes. Training material shall be maintained for the induction of new staff to the Office. 4.5 Records Records are documents that are produced through the operation of OHIMs processes and that serve a specific purpose at that time and point in the process. Records provide evidence of activities performed or state results achieved. Examples are CTM and RCD letters that are sent to customers, and test reports that are produced in projects. Records are identified in the relevant process card. Records are generally not subject to maintenance and revision. The Information Security Management System provides for the secure management of OHIMs records (reference Information Management Security Policy). Control of records is supported by the OHIMs core business IT systems, which retain records of the processing of CTMA, RCD applications, appeals, etc. The unique identification of these applications from customers is also managed by these IT systems. OHIMs approach to record retention is as follows: - Records relating to CTM and RCD applications and appeals are retained indefinitely - Medical records are retained for at least 30 years - Other records are retained for at least 5 years to ensure compliance with legal and standards requirements. Managers are responsible for ensuring that records are not destroyed prematurely, especially IT managers responsible for data storage and Process Managers. Quality Manual_EN.doc Page 17 of 17